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A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram

This study is currently recruiting participants.
Verified January 2013 by Loma Linda University
Sponsor:
Information provided by (Responsible Party):
Deborah McIvor, MD, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01256749
First received: December 2, 2010
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

The fundamental reason for comparing the ability of the Frontal Sedline TM Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for burst suppression detection is to determine if a less expensive, less invasive and possibly more convenient bifrontal EEG monitor can be effective for evaluation of anesthesia-induced intraoperative burst suppression therapy (IBST) for cerebral protection.


Condition
Craniotomy
Transphenoidal Pituitary Resection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram Monitoring for the Evaluation of Intraoperative Burst Suppression During Elective Craniotomy or Transphenoidal Pituitary Resection

Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Correlation between 4 channel PSA EEG and a global 12 lead EEG [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The primary outcome measure is correlation between 4 channel frontal PSA EEG pattern and standard global 12 lead EEG during IBST.


Estimated Enrollment: 25
Study Start Date: December 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients scheduled for elective craniotomy or transphenoidal pituitary resection at LLUMC University Hospital in which the surgeon has requested intraoperative burst suppression therapy regardless of the inciting etiology will be eligible to participate in this study.

Criteria

Inclusion Criteria:

  1. Adult ASA class 1-3 male or female 18-90 years of age;
  2. scheduled for elective craniotomy in the LLUMC University Hospital, for which the surgeon has requested intraoperative burst suppression therapy;
  3. capable of understanding and signing informed consent;
  4. willing to have dual EEG monitoring.

Exclusion Criteria:

  1. Age under 18 years;
  2. emergency or trauma situation requiring craniotomy;
  3. surgical approach that prohibits placing the SEDLineTM array on the forehead;
  4. known sensitivity to the adhesives on the SEDLineTM array;
  5. lack of availability of standard EEG monitoring;
  6. patients with seizure disorders and refusal of consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256749

Locations
United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92354
Contact: Patricia Moore     909-558-8493     pamoore@llu.edu    
Contact: Deborah W McIvor, MD     909-558-4475     dmcivor@llu.edu    
Principal Investigator: Deborah W McIvor, MD            
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Deborah W McIvor, MD Loma Linda University
  More Information

No publications provided

Responsible Party: Deborah McIvor, MD, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01256749     History of Changes
Other Study ID Numbers: 5100294
Study First Received: December 2, 2010
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013